Amputees Diving Back Into the Water With “The Fin”

Tracey Romero • Mon, April 17th, 2017

The first 3-D-printed amphibious, prosthetic leg dubbed “The Fin” is getting amputee swimmers back into the water after the loss of a limb.

Created by Northwell Health headquartered in New Hyde Park, New York, this swim leg allows amputees to move from land to water with ease. A key part is the 3-D downward-pointing triangle of nylon and plastic which improves propulsion underwater.

In a press release announcing the launch of the new prosthetic, Todd Goldstein, Ph.D., director of Northwell Ventures 3D Printing Laboratory, who designed and fabricated “The Fin” prosthetic said, “The Fin attaches to a standard prosthetic with ease, allowing the amputee to enter and exit the water without changing prosthetics. My hope is that this device creates unforeseen opportunities for amputees everywhere.”

According to the release, 33-year old Marine Corps veteran Dan Lasko, whose leg was amputated below-the-knee after his vehicle hit an explosive device while serving in Afghanistan in 2004, finds the amphibious, prosthetic leg to be a real life changer.

“The Fin is greatly improving my quality of life and allows me to return to my love of swimming. I recently got back in the pool with my two young sons and for the first time was able to dive into the pool with them,” Lasko said in the release. He has completed six marathons and more than 30 triathlons around the country since his injury.

Northwell Health collaborated with Eschen Prosthetic and Orthotic Laboratories in Hicksville and Composite Protoyping Center in Plainview to design and print “The Fin”. Northwell and Eschen hope to continue working together on other customized prosthetic devices to improve the quality of life for amputees.

“The prosthetic market is characterized by one-size-fits-all solutions,” said Thomas Thornton, senior vice president of Northwell Ventures in the release. “For amputees with a passion for swimming, there was no device out there that was truly amphibious and allowed them to really swim.”

To help promote this new prosthetic device, Northwell has launched a multimedia advertising campaign called “The Return” created by advertising agency J. Walter Thompson New York.

“Putting people at the heart of innovation is a big part of looking at healthcare differently and that’s what we set out to do with The Fin,” said Ben James, executive creative director at J. Walter Thompson New York.

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Amputees Controlling Bionic Legs With Their Thoughts

Elizabeth Hofheinz, M.P.H., M.Ed. • Wed, May 27th, 2015

Smart phones…nice! Smart limbs…phenomenal! Thanks to the foresight of those at the Icelandic company Össur, today there are two amputees—the first people in the world—who can control their bionic prosthetic legs with their thoughts. The prosthesis works via implanted myoelectric sensors (IMES) that have been surgically placed in their residual muscle tissue. The IMES, which was provided by the Alfred Mann Foundation, instantaneously triggers the desired movement, via a receiver located inside the prosthesis. This process occurs subconsciously, continuously and in real-time. The bionic limbs are capable of real-time learning and automatically adjusting to their user’s gait, speed and terrain.

According to the May 20, 2015 news release, Thorvaldur Ingvarsson, M.D., Ph.D. is the orthopedic surgeon who leads Össur’s research and development efforts and spearheaded the mind-controlled prosthetics project. He noted that, “movement in able-bodied individuals generally begins subconsciously, which triggers electrical impulses inside the body that catalyze the appropriate muscles into action. Össur’s new technology replicates that process in an amputee: that electronic impulse from the brain is received by an IMES that was surgically placed by Dr. Ingvarsson into muscles in the amputee’s residual limb.”

“The technology allows the user’s experience with their prosthesis to become more intuitive and integrative, ” Dr. Ingvarsson said. “The result is the instantaneous physical movement of the prosthesis however the amputee intended. They no longer need to think about their movements because their unconscious reflexes are automatically converted into myoelectric impulses that control their bionic prosthesis.”

The two amputees have been living with Össur’s mind-controlled bionic prostheses for more than one year. Dr. Ingvarsson notes that feedback from both users has been very positive, and that clinical trials to further assess the technology will continue.

Asked about the challenges involved in placing the sensor in the patient’s residual muscle tissue, Dr. Ingvarsson told OTW, “The challenge is the precise location of the sensors; otherwise, it is a minimally invasive and relatively straightforward surgery for any orthopaedic surgeon.’

As for what patients say, he added, “The patients reported that the main challenge was in fact emotional, in a positive way.”

Amputees Control Prosthetics With Thoughts

Biloine W. Young • Thu, May 21st, 2015

Two amputees, part of a trial in Copenhagen, are the first in the world to control their lower-limb prosthesis with their minds—subconsciously. As reported by Amy Pollock, writing for Reuters, the two have tiny implanted myoelectric sensors (IMES) surgically placed in their muscle tissue. An Icelandic orthopedics company called Össur developed the sensors and they trigger movement via a receiver.

Gummi Olafsson, one of the two amputees, lost his right foot and lower leg years after a childhood traffic accident. The implants worked for him almost instantly, he reported.

Pollock quoted Olafsson as saying, "As soon as I put my foot on, it took me about 10 minutes to get control of it. I could stand up and just walk away. Come back, sit down, use my muscles to move my foot in the position I wanted to use it. It was, like you couldn't believe the feeling when you were moving your ankle. It was really strange. I couldn't explain it. It was like, I was moving it with my muscles, there was nobody else doing it, the foot was not doing it, I was doing it, so it was really strange and overwhelming.”

The 5 millimeters long and 3 millimeters wide Implanted Myoelectric Sensors were provided by the U.S.-based Alfred Mann Foundation, which develops medical technology for use in patients.

Pollock reports that Olafsson’s body continues to adapt to his prosthetic limb more each day, allowing him increased control of it.

"Your muscles are always getting bigger…. So everyday if you are using it, you're always getting more and more control over what you're doing with your foot, so in a way, everyday you're learning more about how to walk properly with the foot, how to use it to go downhill, uphill, downstairs, upstairs, even sitting down and standing up from a chair, " Olafsson said.

Orthopedic surgeon and Össur's director of research and development, Dr. Thorvaldur Ingvarsson, implanted the sensors in the two patients involved in the trial. He said that the sensors allow the patient's brain to control both subconscious and intentional movements.

He explained, "So, the brain power, when it takes over, it actually gives impulses through the brain into the muscles, then the muscles contract.

Largest Amputee Study to Date: Quality of Life Data

Elizabeth Hofheinz, M.P.H., M.Ed. • Thu, October 26th, 2017

In a retrospective study of 550 amputees, the largest such study to date, researchers from Hanger Clinic, based in Austin, Texas, have advanced evidence-based care for amputees. The results of their study in lower limb amputees, known as the Mobility Analysis of Amputees (MAAT I), measured the correlation of mobility to quality of life and patient satisfaction for people living with lower limb loss. The result? They discovered a significant direct correlation.

As Hanger wrote in its October 10, 2017 news release, “Colleagues in the clinical and scientific affairs department of Hanger Clinic, including James Campbell, Ph.D., C.O., F.A.A.O.P., Shane R. Wurdeman, Ph.D., C.P., F.A.A.O.P., and Phil M. Stevens, M.Ed., C.P.O., F.A.A.O.P., began the study by performing a retrospective review of outcomes data collected within multiple clinics. Included with the data obtained was the Prosthetic Limb Users Survey of Mobility and Prosthesis Evaluation Questionnaire. Analysis included 509 current prosthetic users, individuals age 18 or older, with varying amputation levels, including both unilateral and bilateral lower limb amputation.”

James Campbell, Ph.D., C.O., F.A.A.O.P., chief clinical officer of Hanger Clinic, told OTW, “Restoration of mobility is considered a primary objective of rehabilitation following lower limb amputation, however studies investigating the relationship between mobility and both satisfaction and quality of life have been limited. The purpose of this study was to examine the direct relationship between lower limb prosthesis users’ mobility and both satisfaction and quality of life.”

“Regarding study design and data collection, an obvious strength of this study was the high number of patients. A retrospective review of 550 patients utilizing a lower limb prosthesis was performed across multiple clinics that provide lower limb prosthetic care. Following removal of incomplete data sets and patients that did not meet inclusion/exclusion criteria, there were 509 patients included for analysis.”

“The results of the study confirm the positive relationships between both constructs (i.e., general satisfaction and quality of life) and patient mobility.

New Leg Prosthesis Gains FDA Approval

Biloine W. Young • Wed, July 22nd, 2015

The conventional treatment for an amputation above the knee is a specially fitted cup-like shell called a socket. It fits over the remaining portion of the patients’ leg and helps secure the device to the leg. If patients do not have a long enough residual limb to properly fit socket prosthesis or have other conditions, such as scarring, pain, recurrent skin infections, or fluctuations in the shape of the residual limb they are just out of luck.

To remedy that situation the FDA has authorized the first prosthesis to be marketed in the U.S. for patients who cannot use the conventional socket prosthesis. The device is called the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA). It uses fixtures and screws that are implanted into the patient’s remaining thigh bone to connect an external limb.

According to the FDA press release, the OPRA device is installed with two surgical procedures. In the first procedure, a cylinder-shaped fixture is implanted into the central canal of the remaining thigh bone. Approximately six months later, after tissue has grown to anchor the fixture and the skin tissue has healed, a second surgery is performed to implant a rod that attaches to the fixture from the previous surgery. This rod extends through the skin at the bottom of the patient’s residual limb and connects to the prosthetic leg.

After the second surgery, the patient works with a specially trained physical therapist to gradually place weight on the OPRA device using a training prosthesis. Patients require about six months of training and rehabilitation after the second surgery, before being fitted with their own customized prosthesis.

“Prostheses can help people who have lost a leg due to trauma or cancer to regain mobility and to more easily participate in everyday activities, ” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “The OPRA device may help those with above-the-knee amputations who have had problems with rehabilitation and have not been able to benefit from available socket prostheses.”

Touch-Sensitive Prosthetic Limbs: Progress!

Elizabeth Hofheinz, M.P.H., M.Ed. • Mon, October 21st, 2013

New research at the University of Chicago is laying the groundwork for touch-sensitive prosthetic limbs that one day could convey real-time sensory information to amputees via a direct interface with the brain.

“To restore sensory motor function of an arm, you not only have to replace the motor signals that the brain sends to the arm to move it around, but you also have to replace the sensory signals that the arm sends back to the brain, ” said the study's senior author, Sliman Bensmaia, Ph.D., assistant professor in the Department of Organismal Biology and Anatomy at the University of Chicago, in the October 14, 2013 news release. “We think the key is to invoke what we know about how the brain of the intact organism processes sensory information, and then try to reproduce these patterns of neural activity through stimulation of the brain.”

Bensmaia’s research is part of Revolutionizing Prosthetics, a multi-year Defense Advanced Research Projects Agency (DARPA) project that seeks to create a modular, artificial upper limb that will restore natural motor control and sensation in amputees. Managed by the Johns Hopkins University Applied Physics Laboratory, the project has brought together an interdisciplinary team of experts from academic institutions, government agencies and private companies.

Bensmaia and his colleagues at the University of Chicago are working specifically on the sensory aspects of these limbs. Using monkeys, the researchers identified patterns of neural activity that occur during natural object manipulation and then successfully induced these patterns through artificial means. The first set of experiments focused on contact location, or sensing where the skin has been touched. The animals were trained to identify several patterns of physical contact with their fingers. Researchers then connected electrodes to areas of the brain corresponding to each finger and replaced physical touches with electrical stimuli delivered to the appropriate areas of the brain. The result was that the animals responded the same way to artificial stimulation as they did to physical contact.

When the researchers focused on the sensation of pressure they developed an algorithm to generate the appropriate amount of electrical current to elicit a sensation of pressure.